2021 Enforcement Review: FDA-Regulated Medical Products
While the continuing COVID-19 public health emergency remained an obstacle to many Food and Drug Administration (“FDA”) inspections in 2021, the pandemic did not preclude criminal and civil enforcement actions related to core FDA regulatory violations, especially those matters that have been under investigation since before the pandemic. The Department of Justice (“DOJ”) announced numerous indictments, civil and criminal settlements and criminal sentences involving those accused of violating the Federal Food, Drug, and Cosmetic Act (“FDCA”) and other laws in connection with schemes involving FDA-regulated products. COVID-19 related fraud remained a top priority as did cases involving opioids and clinical trial fraud.
This 2021 enforcement review covers key criminal and civil enforcement actions against life sciences companies, starting with those related to the ongoing COVID-19 pandemic. It turns next to actions involving the illicit distribution of opioids, which continue to be a DOJ priority, and then focuses on an emerging area of law enforcement interest: clinical trial fraud. The article then looks at other enforcement actions brought under the FDCA and related criminal statutes, as well as the civil False Claims Act, that are predicated upon a somewhat wider variety of alleged FDA regulatory violations. The article wraps up by looking forward to what FDA-regulated companies can expect on the enforcement horizon in 2022.